STA-R MAX 59012

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-07-22 for STA-R MAX 59012 manufactured by Diagnostica Stago S.a.s..

MAUDE Entry Details

Report Number8043273-2019-00007
MDR Report Key8811851
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-07-22
Date of Report2019-05-15
Date of Event2019-04-02
Date Facility Aware2019-07-16
Report Date2019-07-22
Date Reported to FDA2019-07-22
Date Mfgr Received2019-05-15
Device Manufacturer Date2018-05-31
Date Added to Maude2019-07-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. WALID BEN AMMAR
Manufacturer Street2 RUE PIERRE FOSSATI
Manufacturer CityFRANCONVILLE, 95130
Manufacturer CountryFR
Manufacturer Postal95130
Manufacturer G1DIAGNOSTICA STAGO S.A.S.
Manufacturer Street3 ALL
Manufacturer CityASNI 92600
Manufacturer CountryFR
Manufacturer Postal Code92600
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTA-R MAX
Generic NameIVD COAGULATION DEVICE/INSTRUMENT
Product CodeJPA
Date Received2019-07-22
Model Number59012
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 YR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDIAGNOSTICA STAGO S.A.S.
Manufacturer Address3 ALL?E TH?R?SA ASNI?RES-SUR-SEINE, 92600 FR 92600


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-22

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